BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM LT SZ 3

    MDR report key: 1190377 · Received October 3, 2008

    Report

    Report Number
    1818910-2008-04302
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, INFO PROVIDED SUGGESTS THAT POSITIONING OF THE IMPLANT DURING THE INITIAL IMPLANTATION MAY HAVE BEEN A CONTRIBUTING FACTOR. NO EVIDENCE WAS FOUND THAT WOULD SUGGEST PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATIVE FINDINGS, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF THE FEMORAL COMPONENT WAS TOO VALGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM LT SZ 3 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA 397043DC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention